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www.biopharminternational.com October 2020 BioPharm International eBook 27 Regulatory Sourcebook Data Integrity the left-hand side of Figure 5 are the same steps from Figure 4, now bro- ken down into 25 individual pro- cess steps with associated actions and calculations (see Figure 6 for details) to generate the analytical record for review. In this example, the laboratory has chosen to make the test in duplicate. APPLY ALCOA+ REQUIREMENTS To illustrate an approach to apply- ing the ALCOA+ requirements to pharmacopeial testing, consider a LOD analysis for betamethasone valerate interpreted in Figure 4 and Figure 5. Figure 6 contains a detailed description of the 25 analytical process steps involved in a LOD analysis according to USP <731> (16); the next column lists the doc- umentary evidence produced at each step, and the nine columns to the right list the nine ALCOA+ requirements. If a criterion applies at a test step, then a tick is placed in the appropriate column. The following assumptions are made in Figure 6: • Complete is only recorded at end of the analysis, as it is the responsibility of both the per- former and reviewer to ensure completeness. • Balance printouts are assumed to be legible and therefore this is not recorded in the table. • "Consistent and enduring" are applicable throughout the pro- cess, so only one entry is made for the whole analysis. I t m i g h t a p p e a r t h a t t h i s approach is burdensome, but the majority of such procedures are generic and, once a particular pro- cedure is mapped, it is reusable many times across monographs, with minor modifications. SUMMARY AND RECOMMENDATION Pha r macopoeias a re evolut ion- ary documents with long times- ca les a nd legac y requ irements. This slow evolution is based upon regulatory and consumer-driven n e e d s a s w e l l a s a l i g n m e n t w ith best analy tical and scien- tif ic prac tices. Phar macopoeias a re la rge, comple x comp e nd ia a nd a re a mended a nd updated by expert committee and panel st r uc t u res t hat a re not a lways coordinated. T h e b l e n d o f c l a s s i c a l a n d no n - c l a s s ic a l te s t i n g r e q u i r e - ments to meet a standard make it d if f ic u lt for t he prac t it ioner to comply with modern reg ula- tory expectations regarding data integrit y. A formal requirement is necessary in the pharmacopeia as to the necessit y for detailed inter pretation of testing proce- du res re qu i re d to a ssu re com- p l i a n c e w it h t h e m o n o g r a p h standard and current regulatory best practice. For example, USP shou ld have eit her a n e x pl ic it statement in the General Notices or General Chapter below 10 0 0 explicitly requiring a that a doc- umented, detailed analytical test interpretation is needed for each monograph test, with cross-ref- e r e nc e s t o t he i n fo r m at io n a l General Chapter <1029>. REFERENCES 1. MHRA, GMP Data Integrity Definitions and Guidance for Industry, 2nd Edition (2015). 2. MHRA, GXP Data Integrity Guidance and Definitions (2018). 3. WHO, Technical Report Series No.996, Annex 5 Guidance on Good Data and Records Management Practices (2016). 4. FDA, Guidance for Industry Data Integrity and Compliance With Drug CGMP Questions and Answers (2018). 5. PIC/S, PI-041-3 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments Draft (2018). 6. ISPE, GAMP Guide Records and Data integrity (2017). 7. ISPE, GAMP Good Practice Guide: Data Integrity - Key Concepts (2018). 8. PDA, Technical Report 80: Data Integrity Management System for Pharmaceutical Laboratories (2018). 9. APIC Data Integrity Task Force, Practical Risk-Based Guide for Managing Data Integrity, Version 1 (2019). 10. C Burgess, Pharm. Tech., 41 (10) 82-83, 92 (2017) 11. USP, USP General Notices and Requirements, (Rockville, MD, 2020). 12. USP, USP General Chapter <1225> "Validation of Compendial Procedures," USP 42-NF 37 (Rockville, MD, 2020). 13. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (2005). 14. USP, USP General Chapter <1029> "Good Documentation Guidelines," USP 42-NF 37 (Rockville, MD, 2020). 15. CFR Title 21, Part 211 Current Good Manufacturing Practice for Finished Pharmaceutical Products (2008). 16. USP, USP General Chapter <731> "Loss on Drying" USP 42-NF 37 (Rockville, MD, 2020). 17. USP, USP General Chapter <1226> "Verification of Compendial Procedures" USP 42-NF 37 (Rockville, MD, 2020). 18. USP, USP General Chapter <1058> "Analytical Instrument Qualification," USP 42-NF 37 (Rockville, MD, 2020). 19. C. Burgess and R.D. McDowall, LC-GC Europe 29 (9) 498-504 (2016). 20. R.D.McDowall, Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories (Cambridge: Royal Society of Chemistry, 2019). 21. EMA, Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials (London, 2010). 22. USP, USP General Chapter <41> "Balances," USP 42-NF 37 (Rockville, MD, 2020). 23. S.W.Wollen, "Data Quality and the Origin of ALCOA in The Compass, Newsletter of the Southern Regional Chapter, Society of Quality Assurance (Summer 2010). 24. USP, USP General Chapter <1251> "Weighing on an Analytical Balance," USP 42-NF 37 (Rockville, MD, 2020). BP Pharmacopoeias are evolutionary documents with long timescales and legacy requirements.